FRIDAY, Aug. 16, 2019 (HealthDay News) -- The Tether -- Vertebral Body Tethering System has been approved to correct idiopathic scoliosis in children and adolescents who have not responded to conservative treatment, the U.S. Food and Drug Administration announced today.
The device is the first spinal tether device approved for this indication and offers an alternative to fusion surgery when idiopathic scoliosis does not respond well to bracing. The Tether -- Vertebral Body Tethering System is designed to continue to correct a patient's curvature as they grow while maintaining fuller range of motion compared with spinal fusion. The device includes anchors and vertebral body screws placed into the same side of each vertebra in the curved part of the spine through an incision on the side of the chest. A tether is then connected to the screws. During surgery, tension is applied to the tether to compress one side of the spine and partially correct the curve. The tether slows growth on the curved side of the spine over time, while promoting growth on the other side to additionally correct the curve as the patient grows.
The Tether -- Vertebral Body Tethering System is not meant to be removed unless overcorrection or other problems occur. Health care professionals should monitor patients with follow-up X-rays to track the spinal curvature and identify any problems that could require revision or removal of the device. Spinal fusion is still possible for patients who do not achieve adequate correction with the device.
FDA approval of the Tether -- Vertebral Body Tethering System was based on clinical data from 57 patients who received the device. Two-year data revealed that 43 patients had sufficient improvement in the curvature of the spine and did not require spinal fusion. The most commonly reported serious adverse reactions included curvature overcorrection, tether breakage, and pneumothorax. General complications included pain, respiratory problems, nerve injuries, and bleeding.
Approval of the device was granted to Zimmer Biomet Spine, which is partnering with the Harms Study Group to develop a patient data registry to assess the long-term performance of the Tether -- Vertebral Body Tethering System.